FDA WARNING_LETTER - Spectrum Laboratory Products, Inc. - November 16, 2018

The FDA inspected Spectrum Laboratory Products, Inc. (Spectrum) from November 8-16, 2018, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their drugs adulterated.

Key violations include: 1. **Failure to transfer complete quality/regulatory information:** Spectrum omitted original API manufacturer names and addresses on Certificates of Analysis (COA) and labels for repackaged APIs, including opioids like fentanyl citrate and morphine sulfate. This compromises supply chain accountability. The FDA requires a remediated COA program, a retrospective review of affected drugs, and examples of new COAs with original manufacturer information. 2. **Inadequate quality unit investigations:** Spectrum failed to thoroughly investigate critical deviations (e.g., a cracked Buprenorphine HCl bottle) and customer complaints (e.g., fluconazole batch variation), lacking root cause analysis and corrective actions. The FDA demands full investigation reports and a comprehensive assessment of their CAPA system.

Additionally, Spectrum commercially distributes acetylcysteine, doxylamine, pyrimethamine, tamoxifen, and trichlormethiazide, which are not listed with the FDA, making them misbranded. Opioid APIs (fentanyl citrate, hydrocodone bitartrate, buprenorphine hydrochloride, hydromorphone hydrochloride, morphine sulfate, and nalbuphine hydrochloride) are also misbranded because their labels falsely imply Spectrum is the sole manufacturer